A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stro… (NCT02838069) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
France100 participantsStarted 2016-09-20
Plain-language summary
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.
The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.
This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
* Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
* NSAID washout of at least 2 days before screening/baseline
Exclusion Criteria:
* Previous treatments acting on cartilage or bone metabolism
* Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
* Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
* Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
* Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
* History of joint replacement of the knee or hip within the previous 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.